MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problem Misconnection (1399)

Patient Problem Respiratory Distress (2045)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint airvo humidifier was received at our fisher & paykel healthcare (fph) regional office in (b)(4) and was inspected by a trained fph technician.Our investigation is based on the test report and photographs provided by the technician.The device was visually inspected and performance tested.Results: visual inspection of the subject airvo revealed that the filter cover was not seated correctly in the back of the airvo and was not fully attached.We note that the oxygen inlet of the airvo is located on the filter cover.The filter cover was properly connected for performance testing.The subject airvo was found to function within specification with no faults or defects.Additionally, the airvo log showed multiple "check for leaks" warnings displayed on the date of the incident.Conclusion: supplemental oxygen is fed into the airvo via the filter cover.If the airvo had been operated with the filter cover improperly re-attached, only ambient air would have been entrained and the oxygen fraction would have been 21%, as noted by the complainant.The airvo would have also displayed a "check for leaks" warning as confirmed during review of the airvo log.The airvo user manual states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" and that "the unit is not intended for life support." it also states "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." the user manual warns the user: - oxygen must only be added through the special oxygen inlet port on the back of the unit.To ensure that oxygen enters the unit correctly, the oxygen inlet port must be fitted properly to the filter holder and the filter holder must be fitted properly to the unit.Following this incident, further training with the hospital has been scheduled.

Event Description

A hospital in (b)(6) reported that the oxygen display of an airvo 2 humidifier dropped from 60% to 21% during use and did not increase when hospital staff increased the oxygen flow.Shortly after, the patient "had an episode of poor respiratory effort which required bag valve mask intervention." the patient then stabilised and there was no further consequence.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7137036
• MDR Text Key: 96035805
• Report Number: 9611451-2017-01223
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 150518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1